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DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00024401
First Posted: January 15, 2004
Last Update Posted: July 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer Drug: DHA-paclitaxel Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
Detailed Description:

OBJECTIVES: I. Determine the objective tumor response rate, duration of response, and time to disease progression in patients with metastatic colorectal cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at end of study treatment. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cancer of the colon or rectum Clinical evidence of metastatic disease Failed 1 prior chemotherapy regimen for metastatic disease Measurable disease No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No unstable or serious concurrent medical condition No concurrent serious infection requiring parenteral therapy No other prior malignancy except: Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Other cancer curatively treated with surgery alone that has not recurred for more than 5 years No psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen for metastatic disease No prior taxanes At least 28 days since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: At least 28 days since prior large-field radiotherapy and recovered No concurrent radiotherapy Surgery: At least 14 days since prior major surgery and recovered

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024401


Locations
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85712-2254
United States, District of Columbia
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
Sponsors and Collaborators
Theradex
Investigators
Study Chair: Ross C. Donehower, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00024401     History of Changes
Other Study ID Numbers: CDR0000068929
THERADEX-P01-00-01
ABCCC-010505
PROTARGA-P01-00-01
First Submitted: September 13, 2001
First Posted: January 15, 2004
Last Update Posted: July 24, 2008
Last Verified: June 2002

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action